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Overview

Pharmaceutical dose form concepts (e.g. conventional release oral tablet, prolonged-release oral capsule) that are deemed to be clinically useful and that can be sufficiently defined will be included in the 736542009 |Pharmaceutical dose form (dose form)| hierarchy.  Primitive concepts may be included if documented as an exception.

Modeling (stated view)

Pharmaceutical dose form concepts shall be modeled as follows:

Parent concept

736542009 |Pharmaceutical dose form (dose form)

Semantic tag

(dose form)

Definition status

900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)|

  • Exceptions:
    • The following concepts cannot be sufficiently defined and will be modeled with the parent concept 736542009 |Pharmaceutical dose form (dose form) and all applicable attributes but will have a Definition status = 900000000000074008 |Necessary but not sufficient concept definition status (core metadata concept); these concepts should classify as leaf nodes in the hierarchy.
      • Concepts that refer to "coated" (e.g. 421338009 |Prolonged-release oral coated capsule (dose form)|)
      • Concepts that refer to "drug delivery system" (e.g. 784576003 |Prolonged-release intrauterine drug delivery system (dose form)|)
      • Concepts that refer to "iontophoresis" (e.g. 385113008 |Conventional release solution for iontophoresis (dose form)|)
      • Concepts that refer to "liposomal suspension" (e.g. 420656008 |Lyophilized powder for conventional release liposomal suspension for injection (dose form)|)
      • Concepts that refer to "nebulizer" (e.g. 385198000 |Conventional release solution for nebulizer (dose form)|)
      • Concepts that refer to "pellet" or "particle" (e.g. 420767002 |Gastro-resistant oral pellets capsule (dose form)| or 421535006 |Gastro-resistant oral particles tablet (dose form)|)
      • Concepts that refer to "syrup" (e.g. 385033009 |Powder for conventional release oral syrup (dose form)|)
      • Concepts that refer to "vapor" (e.g. 385215007 |Conventional release vapor ointment for inhalation (dose form)|)

Attribute:

Has basic dose form

  • Range: 736478001 |Basic dose form (basic dose form) - descendants only
  • Cardinality: 0..1
    • While the allowed range is broader, concepts representing a sufficiently defined pharmaceutical dose form should have one and only one |Has basic dose form| attributes.

Attribute:

Has dose form intended site

  • Range: 736479009 |Dose form intended site (intended site) - descendants only
  • Cardinality: 0..*
    • While the allowed range is broader, concepts representing a sufficiently defined pharmaceutical dose form should have one or more |Has dose form intended site| attributes.
  • Exceptions:
    • 785898006 |Conventional release solution for irrigation (dose form)|
    • 785910004 |Prolonged-release intralesional implant (dose form)|

Attribute:

Has dose form release characteristic

  • Range: 736480007 |Dose form release characteristic (release characteristic) - descendants only
  • Cardinality: 0..1
    • While the allowed range is broader, concepts representing a sufficiently defined pharmaceutical dose form should have one and only one |Has dose form release characteristic| attributes.

Attribute:

Has dose form administration method

  • Range: 736665006 |Dose form administration method (administration method) - descendants only
  • Cardinality: 0..*
    • While the allowed range is broader, concepts representing a sufficiently defined pharmaceutical dose form should have one and only one |Has dose form administration method| attributes.


Attribute:

Has dose form transformation

  • Range: 736477006|Dose form transformation (transformation) - descendants only
  • Cardinality: 0..*
    • While the allowed range is broader, concepts representing a sufficiently defined pharmaceutical dose form should have one and only one |Has dose form transformation| attributes

Naming Guidelines

FSN

Use the following pattern for the FSN; align naming and case sensitivity with the FSN for the concepts that are selected as the attribute values, excluding the semantic tag. For multiple intended sites, the sites must be in alphabetical order and separated by the word “or”.

  • <Dose form release characteristic FSN> <Dose form intended site FSN> <Basic dose form> (dose form)

Example:

  • Conventional release oral capsule (dose form)
  • Conventional release oral suspension (dose form)
  • Prolonged-release oral capsule (dose form)
  • Conventional release and prolonged-release oral tablet (dose form)
  • Conventional release cutaneous cream (dose form)
  • Conventional release vaginal ointment (dose form)
  • Gastro-resistant oral suspension (dose form)

Preferred Term

Use the following pattern for the PT; align naming and case sensitivity with the PT for the concepts that are selected as the attribute values, excluding the semantic tag. For multiple intended sites, the sites must be in alphabetical order and separated by the word “or”. Exclude <Dose form release characteristic> when = 736849007 |Conventional release (release characteristic)|.

  • <Dose form release characteristic FSN> <Dose form intended site FSN> <Basic dose form>

Example:

  • Oral capsule
  • Oral suspension
  • Prolonged-release oral capsule
  • Conventional release and prolonged-release oral tablet
  • Cutaneous cream
  • Vaginal ointment
  • Gastro-resistant oral suspension

Synonyms

A synonym matching the FSN is required; other synonyms are not allowed unless explicitly identified as an exception in the Editorial Guidelines.

Exceptions:

  • Synonyms with eye instead of ocular, ear instead of otic, or nose instead of nasal may be created
Text DefinitionsOptional

Exemplar

The following illustrates the stated view for 385024007 |Conventional release oral suspension (dose form)|:

The following illustrates the inferred view for 385024007 |Conventional release oral suspension (dose form)|:

The following illustrates the stated view for 764774009 |Conventional release and prolonged-release oral tablet (dose form)|:


The following illustrates the inferred view for 764774009 |Conventional release and prolonged-release oral tablet (dose form)|:



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